BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFUSE INTERVERTEBRAL BODY FUSION SYSTEM

    MDR report key: 1565040 · Received December 18, 2009

    Report

    Report Number
    3007617183-2009-00003
    Event Type
    Injury
    Date Received
    December 18, 2009
    Date of Event
    November 23, 2009
    Report Date
    December 18, 2009
    Manufacturer
    VERTEBRAL TECHNOLOGIES INC.
    Product Code
    MAX
    PMA / PMN Number
    K091988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR ELECTED TO IMPLANT THE INTERFUSE DEVICE THROUGH A MINIMALLY INVASIVE TLIF RATHER THAN A UPLIF SURGICAL APPROACH. THIS REQUIRES THAT THE INTERFUSE MODULES BE IMPLANTED AT AN ANGLE AND MAKES IT HARD TO LOCK THE MODULES TOGETHER. DOING THE PROCEDURE THROUGH AN 18MM CANNULA MAKES IT VERY DIFFICULT TO VISUALIZE THE PLACEMENT OF THE MODULES OR TO DETERMINE BY VISUAL AND TACTILE MEANS IF THE MODULES ARE LOCKED TOGETHER. DR ALSO USED UNILATERAL PEDICLE SCREW FIXATION ON THE CONTRALATERAL SIDE OF THE DISC AND COMPRESSED IT AFTER COMPLETING THE INTERFUSE DEVICE IMPLANTATION. HE SUSPECTS THAT THIS MAY HAVE PUSHED THE INTERFUSE DEVICE BACK THOUGH THE ANNULOTOMY. HE DID NOT CONFIRM THE PLACEMENT OF THE INTERFUSE DEVICE AFTER COMPRESSING THE PEDICLE SCREW CONSTRUCT AND BEFORE CLOSING.

    Description of Event or Problem · 1

    FEMALE PATIENT WAS TREATED AT L4-L5 USING A FOUR MODULE INTERFUSE DEVICE AND UNILATERAL PEDICLE SCREW FIXATION ON THE CONTRALATERAL SIDE. POST-OP PATIENT'S BACK AND THIGH PAIN HAD RESOLVED BUT SHE COMPLAINED OF A BURNING SENSATION AND PAIN IN HER BACK, LEG AND FOOT CONSISTENT WITH DORSAL ROOT GANGLION SYNDROME. MRI/CT STUDIES SHOWED THE LAST MODULE OF THE INTERFUSE DEVICE HAD MIGRATED POSTEROLATERALLY INTO THE FORAMEN. PATIENT'S SYMPTOMS WERE IMPROVING WITH MEDICATION BUT DR ELECTED TO EXPLORE THE LEVEL SURGICALLY. HE FOUND THE LAST TWO MODULES IMPLANTED HAD MIGRATED AND WERE UNDER THE L4 NERVE ROOT. HE ALSO FOUND THE A MODULE HAD NOT BEEN FULLY ENGAGED WITH THE FIRST B MODULE DURING THE INITIAL SURGERY. HE REMOVED ALL FOUR INTERFUSE MODULES, REMOVED MORE OF THE NUCLEUS PULPOSUS, AND IMPLANTED A NEW FOUR MODULE INTERFUSE DEVICE AFTER PACKING BONE GRAFT IN THE CONTRALATERAL SIDE OF THE DISC SPACE. HE ALSO ADDED A SECOND PEDICLE SCREW CONSTRUCT ON THE IPSILATERAL SIDE. POST-OP X-RAYS AND CT SCAN SHOW ALL FOUR MODULES LOCKED TOGETHER AND THE DEVICE PROPERLY ALIGNED IN THE DISC SPACE. PATIENT IS RECOVERING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFUSE INTERVERTEBRAL BODY FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX VERTEBRAL TECHNOLOGIES INC. 9076-10-20-5 090901-04

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R